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NLJ article: FDA Fine-Tunes Generic Biologic Approval Process, Alarms Investors


NEW YORK, March 17, 2011 -- In the March 14, 2011 issue of The National Law Journal, Baker Botts special counsel Steven Lendaris wrote about how the Food and Drug Administration (FDA) in its move to fine-tune the generic biologic approval process has alarmed investors.

In his article, Lendaris noted that on March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act. Under the terms of the BPCIA, the U.S. Food and Drug Administration is charged with developing an approval process to bring generic biologic medicines (that is, medicines generally derived from genetically manipulated living cells or organisms) to market.

Although the FDA is recognized as having significant latitude in interpreting and applying the BPCIA, the FDA’s recent interpretation of a key provision of the act has caused an uproar in the biotechnology industry and has elicited strongly worded letters from certain members of the U.S. House of Representatives and the U.S. Senate.

In the year since the BPCIA was signed into law, both innovator-drug companies and generic-drug manufacturers have shown a keen interest in how certain provisions of the BPCIA will be interpreted by the FDA. One closely watched provision outlines the two distinct terms of exclusivity an innovator company will enjoy before a generic manufacturer can market its version of a biologic medicine.

During the first term, which runs for the first four years after a biologic medicine is approved, the FDA is barred from reviewing a marketing application from a potential generic competitor. During the second term, which runs for the first 12 years after a biologic medicine is approved, the FDA is barred from approving a marketing application from a potential generic competitor. So when the FDA tipped its hand as to how it intends to interpret this provision, various stakeholders were quick to respond.

Lendaris’ complete NLJ article is available here.

About Baker Botts L.L.P.
Baker Botts L.L.P., dating from 1840, is a leading international law firm with offices in Abu Dhabi, Austin, Beijing, Dallas, Dubai, Hong Kong, Houston, London, Moscow, New York, Palo Alto, Riyadh and Washington. With approximately 700 lawyers, Baker Botts provides a full range of legal services to international, national and regional clients. For more information, please visit

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